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Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer

NCT01130025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-02-24

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Warfarin

Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®.

DRUG

Innohep®

Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Agnes Y. Y. Lee, MD, MSc, FRCPC · Director of Thrombosis, Division of Hematology, University of British Columbia, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-04-30
Completion
2014-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130025 on ClinicalTrials.gov